KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion 
Crossing Cultures LLC dba Goddess Garden

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kids Natural Mineral Sunscreen Broad Spectrum SPF 30 Lotion

Drug Facts

Active Ingredients

Titanium Doxide 6.4%, Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

Warnings

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure. • Reapply: • After 40 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. • Children under 6 months of age: Ask a doctor. • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am to 2pm. • Wear long-sleeved shirts, pants, hats and sunglasses.


Other Information

• Protect this product from excessive heat and direct sun. • Store at temperatures below 90°F. • May stain some fabrics.

Inactive Ingredients

Aloe Barbadensis Leaf Juice*, Aluminum Hydroxide, Butyrospermum Parkii (Shea Butter)*, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride (Coconut Oil), Carthamus Tinctorius (Safflower) Seed Oil*, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil*, Lavandula Angustifolia (Lavender) Oil*, Lavandula Hybrida (Lavandin) Oil*, Polyhydroxystearic Acid, Sorbitan Oleate, Stearic Acid, Tocopherol (Vitamin E), Water, Xanthan Gum *Certified Organic

Questions or Comments

Toll-free 1-855-SAFE-SUN or

www.GoddessGarden.com

Package Labeling:

Label9

KIDS NATURAL MINERAL SUNSCREEN BROAD SPECTRUM  SPF 30
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
LAVANDIN OIL (UNII: 9RES347CKG)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58479-038-0028 g in 1 TUBE; Type 0: Not a Combination Product01/16/2016
2NDC:58479-038-0196 g in 1 TUBE; Type 0: Not a Combination Product01/16/2016
3NDC:58479-038-02170 g in 1 TUBE; Type 0: Not a Combination Product01/16/2016
4NDC:58479-038-036 g in 1 PACKET; Type 0: Not a Combination Product01/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/16/2016
Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

Revised: 12/2016
Document Id: 42a2192b-106e-0f9d-e054-00144ff8d46c
Set id: 5bccb774-b3f7-47e0-956c-e6d37c6a7d92
Version: 3
Effective Time: 20161201
 
Crossing Cultures LLC dba Goddess Garden